DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a national stage entry under 35 USC 371 of PCT/US2021/53912 filed 7 October 2021, which claims the benefit of domestic priority from US Provisional Application no. 63/088,829 filed 7 October 2020.
Election/Restrictions
Applicant’s election without traverse of Invention I, Species C, pertaining to claims 1, 5, and 8 in the reply filed on 14 October 2025 is acknowledged.
Claims 2-4, 6, 7, and 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II and species A, B, D, and E, there being no allowable generic or linking claim. Election was made without traverse in the reply.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shuros et al. (WO 2022/020591).
In regard to claim 1, Shuros et al. disclose a system for performing integrated mapping and electroporation (para 55-56, Shuros et al. is directed to a hybrid ablation catheter 100 for electroporation and another operation mode such as mapping), the system comprising: a basket catheter (i.e., electrode assembly 220 of figure 2A construed as resembling a basket shape) that includes a plurality of splines 204 (para 76-77), and a plurality of electrodes 208 and 210 mounted to each spline 204 in the plurality of splines 204 (para 76-78); and a controller device 140 (figure 1, para 55) connected to the basket catheter 220, wherein the controller device 140 includes a processor (para 61) configured to activate at least a subset of electrodes to perform electroporation (para 58, a specific set of electrodes can be activated by the controller 140 for an operation mode, wherein a “specific set” considered synonymous with “subset”; additionally, each electrode is individually addressable, para 57), wherein activation of at least the subset of electrodes generates current paths between electrodes on a given spline and between electrodes on adjacent splines (para 60, the electroporation controller 140 is configured to model the electric fields that can be generated by the catheter 110, which often includes consideration of the physical characteristics of the electroporation ablation catheter 110 including the electrodes and spatial relationships of the electrodes on the electroporation ablation catheter 110; the “spatial relationships of electrodes” as used to generate the electric field therein is considered to comprise current paths between electrodes).
In regard to claim 5, Shuros et al. further comprises an electroporation generator 150 (para 55, pulse generator) that is in communication with the controller device 140 and connected to the basket catheter 220, wherein the controller device controls the electroporation generator to deliver voltages to the subset of electrodes (para 57, pulse generator 150 delivers electroporation energy of high voltage and short pulses).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shuros et al. (WO 2022/020591) in view of Scharf et al. (US Publication no. 2014/0121470).
In regard to claim 8, Shuros et al. describes the invention substantially as claimed, however does not teach that the controller device is further configured to control agent delivery in conjunction with the electroporation, wherein the agent delivery comprises in-vivo delivery of one or more genes into a heart of a patient.
Shuros et al. does teach that reversible electroporation technique described therein would benefit therapies that deliver in-vivo chemicals, drugs, or DNA into cells since the electroporation increases cell permeability for these substances. This is considered motivation for modifying the catheter of Shuros et al. to include an agent delivery mechanism. Scharf et al. describes a balloon catheter for cardiac mapping and ablation therapies (para 151). In this manner, Scharf et al. is similar in structure and function to be within a similar field of endeavor with Shuros et al. Scharf et al. also teach that the catheter is further configured to control agent delivery for in-vivo delivery of one or more genes (para 64, 155, the system can comprise a device configured to deliver one or more of the following therapies: genetic-agent delivery, cardiac resynchronization, and pharmacologic; para 283 seems to suggest that the catheter includes, among a variety of elements, a drug delivery device which is considered to provide a mechanism for delivering agents to the heart.).
Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the controller of Shuros et al. to control delivery of an agent to the tissue since it is suggested by Shuros et al. to use the catheter is useful in combination with delivery of in-vivo agents and Scharf et al. explicitly teach drug delivery features with a mapping/ablation catheter structure. The modification is considered to comprise the application of a known technique to a known device to yield a predictable result.
Additionally, the recitation that “the agent delivery comprises in-vivo delivery of one or more genes into a heart of a patient” is a recitation of the intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The structure suggested by Scharf et al. for drug delivery is considered capable for this use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hancock et al. (US Patent no. 11,969,208);
Govari et al. (EP 4 079 244);
Govari (US Publication no. 2021/0169421);
Green et al. (US Publication no. 2021/0085931);
Toth et al. (US Publication no. 2018/0303414);
Chou et al. (US Publication no. 2015/0366508);
Bencini et al. (US Publication no. 2012/0165803).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 25 November 2025